Genitourinary Pathogen Nucleic Acid Detection Panel .

UnitedHealthcare CommercialMedical PolicyGenitourinary Pathogen Nucleic Acid Detection PanelTestingPolicy Number: 2021T0608DEffective Date: April 1, 2021Table of ContentsPageCoverage Rationale . 1Definitions . 1Applicable Codes . 2Description of Services . 2Clinical Evidence . 3U.S. Food and Drug Administration . 8References . 8Policy History/Revision Information . 10Instructions for Use . 10 Instructions for UseCommunity Plan Policy Genitourinary Pathogen Nucleic Acid DetectionPanel TestingCoverage RationaleThe following are proven and medically necessary to evaluate symptomatic women for Vaginitis: Direct and amplified DNA probe testing for Trichomoniasis vaginalis Direct probe testing for Candida spDue to insufficient evidence of efficacy, the following are unproven and not medically necessary: Amplified DNA probe testing for vulvovaginitis due to Candida sp Direct and amplified DNA probe testing for bacterial Vaginosis (i.e., Gardnerella vaginalis) Multiplex polymerase chain reaction (PCR) panel testing of genitourinary pathogens, including but not limited to pathogenscommonly associated with VaginitisNote: This policy does not apply to tests for gonorrhea and chlamydia.DefinitionsSexually Transmitted Infection (STI): An STI is an infection that is spread by sexual contact. Infections include chlamydia,gonorrhea, human papillomavirus (HPV), herpes, syphilis, and human immunodeficiency virus (HIV) (American College ofObstetricians and Gynecologists, 2019).Vaginitis: Vaginitis is defined as inflammation or infection of the vagina. The most common causes of Vaginitis includevulvovaginal candidiasis, trichomoniasis, and bacterial Vaginosis (American College of Obstetricians and Gynecologists, 2020).Vaginosis: Vaginosis is caused by the overgrowth of a number of organisms that are normally found in the vagina. It is acommon cause of Vaginitis (American College of Obstetricians and Gynecologists, 2020).Genitourinary Pathogen Nucleic Acid Detection Panel TestingPage 1 of 11UnitedHealthcare Commercial Medical PolicyEffective 04/01/2021Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Applicable CodesThe following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive.Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service.Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that mayrequire coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claimpayment. Other Policies and Guidelines may apply.CPT Code0068UDescriptionCandida species panel (C. albicans, C. glabrata, C. parapsilosis, C. kruseii, C tropicalis, and C. auris),amplified probe technique with qualitative report of the presence or absence of each species81513Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers forAtopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal-fluid specimens,algorithm reported as a positive or negative result for bacterial vaginosis81514Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markersfor Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, Bacterial Vaginosis AssociatedBacteria-2 (BVAB-2), and Lactobacillus species (L. crispatus and L. jensenii), utilizing vaginal-fluidspecimens, algorithm reported as a positive or negative for high likelihood of bacterial vaginosis,includes separate detection of Trichomonas vaginalis and/or Candida species (C. albicans, C. tropicalis,C. parapsilosis, C. dubliniensis), Candida glabrata, Candida krusei, when reported87480Infectious agent detection by nucleic acid (DNA or RNA); Candida species, direct probe technique87481Infectious agent detection by nucleic acid (DNA or RNA); Candida species, amplified probe technique87482Infectious agent detection by nucleic acid (DNA or RNA); Candida species, quantification87510Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, direct probe technique87511Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, amplified probetechnique87512Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, quantification87660Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, direct probe technique87661Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probetechnique87797Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; direct probetechnique, each organism87798Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probetechnique, each organism87799Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; quantification, eachorganism87800Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique87801Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s)techniqueCPT is a registered trademark of the American Medical AssociationDescription of ServicesBacterial Vaginosis (BV), Trichomonas vaginalis (T. vaginalis) and Candida species cause the highest number of cases of acutevulvovaginal symptoms that lead a woman to seek medical care. The physician must assimilate information from the history andphysical examination with information obtained from a vaginal swab to make a diagnosis for the appropriate treatment. Materialfrom the swab can be used to make a determination of vaginal pH, to prepare slides for microscopy, to perform molecular testsand other rapid tests, and to culture organisms.Molecular testing for diagnosis of vaginal infection is based on the detection of one or more specific nucleic acid sequences. InGenitourinary Pathogen Nucleic Acid Detection Panel TestingPage 2 of 11UnitedHealthcare Commercial Medical PolicyEffective 04/01/2021Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

the United States, most molecular assays currently available for Vaginitis/Vaginosis are direct DNA probe tests and nucleic acidamplification tests (Coleman and Gaydos, 2018).The potential use of nucleic acid probe technology for the diagnosis of Vaginitis/Vaginosis was explored in the mid-1990s withthe development of a DNA probe assay. Several manufacturers have now developed nucleic acid amplification tests (NAAT)and panel assays using Polymerase Chain Reaction (PCR) which can detect multiple pathogens. For example, Affirm VPIII, acommercially available DNA probe test, utilizes hybridization of specific organismal sequences to specific labeled DNA probesto detect Candida species, Gardnerella vaginalis (as a marker for BV), and T. vaginalis.Clinical EvidenceCommon Causes of VaginitisThe most common causes of vaginitis include trichomoniasis, bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC).Table 1 describes the main features of these three causes.Table 1. Features of Vaginitis/VaginosisInfectionDischargeCandida speciesThickWhiff testNegativepHNormal ( 4.5)MicroscopyYeasts, hyphaeBacterial vaginosisThin, homogeneousPositive

diagnosis and evaluates the quantity of normal flora versus BV flora. Gram stains may be used in conjunction with Nugent’s criteria to score the samples and categorize them as being normal flora (0-3), intermediate/mixed flora (4-6), or indicative of bacterial vaginosis (7-10) (Coleman and Gaydos, 2018) .